Aseptic connector and method

ABSTRACT

A method for forming an aseptic connection includes inserting an end of a sealed fill connector into a receptacle of an aseptic connector assembly; moving a pivot portion of the aseptic connector assembly relative to a body portion of the aseptic connector assembly so as to sever a portion of the fill connector, the pivot portion being at least partially disposed within the body portion; and advancing a conduit portion of the aseptic connector assembly into the fill connector so as to form an aseptic connection therebetween, the conduit portion being at least partially disposed within the pivot portion or the body portion of the aseptic connector assembly after advancing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.14/476,900, filed on Sep. 4, 2014, which claims priority to, and thebenefit of, U.S. Provisional Patent Application No. 61/979,685, filedApr. 15, 2014, which are hereby incorporated by reference in theirentirety.

FIELD OF THE INVENTION

This invention relates to connectors for fluid transport and moreparticularly to a connector for the aseptic transfer of fluids from onelocation to another.

BACKGROUND OF THE INVENTION

Flexible containers are commonly used for containment and delivery ofmedical fluids. These containers are generally single use bagsmanufactured from one or more types of plastic film that can beirradiated or otherwise withstand sterilization such that the containercan be rendered aseptic. The containers are often used in life scienceapplications and in the manufacture of pharmaceuticals to contain liquidraw materials prior to or during manufacture; in other cases suchcontainers may be used to contain the finished product. The contents ofthese containers may be precious, particularly when used in large scaleproduction. It is not unusual for even small containers to containmaterial worth many thousands of dollars.

Furthermore, it is important that the fluids be capable of quick andefficient transfer between containers, such as from a large capacitycontainer to smaller containers for sale or consumption, withoutcompromising the sterility during transfer. The need to transfer fluidsin sterile conditions introduces additional complications in keepingfluid within a controlled, sterile environment.

Various attempts have been made to deal with this issue and one system,the ASI Filling System commercially available from Advanced Scientifics,Inc. of Millersburg, Pa., can be used to yield an aseptic bag fill. TheASI Filling System is described in U.S. Pat. No. 7,530,374, which isincorporated herein by reference.

While this system presents a satisfactory solution for achieving anaseptically filled container, it is desirable to further enhance thefunctionality of this and other aseptic filling systems.

BRIEF DESCRIPTION OF THE INVENTION

Exemplary embodiments do so by providing a connector that can be used tosubsequently evacuate those containers in an aseptic manner thataccomplishes the filling and subsequent evacuation of the container viathe same port, resulting in a more robust system.

In one embodiment, an aseptic connector assembly includes a bodyportion, the body portion having a receptacle configured to receive acorresponding fill connector; a pivot portion adjustably disposed withinand extending partially from the body portion, the pivot portion havinga channel formed therein; and a conduit portion axially slidablydisposed within the channel formed in the pivot portion. The pivotportion comprises a ready position and an operative position, the pivotportion being adjustable from the ready position to the operativeposition via relative movement with respect to the body portion.

In another embodiment, a fluid transfer assembly includes the asepticconnector assembly, and a fluid container connected to the asepticconnector, the fluid container including a fill connector extendingtherefrom.

In another embodiment, a method of aseptically transferring fluidincludes providing an aseptic connector in a ready position, the asepticconnector including a body portion, the body portion having a receptacleconfigured to receive a corresponding fill connector, a pivot portionadjustably disposed within and extending partially from the bodyportion, the pivot portion having a channel formed therein, and aconduit portion axially slidably disposed within the channel formed inthe pivot portion; coupling a flexible tubing to the conduit portion;coupling the fill connector to the receptacle; moving the pivot portionto an operative position and aligning the conduit portion with thereceptacle; axially sliding the conduit portion into an opening in thereceptacle, establishing a continuous fluid flow path through theaseptic connector; and transferring a fluid from a fluid source, throughthe aseptic connector, to a container.

An advantage of exemplary embodiments is that fluids can be asepticallytransferred without sterilizing an exterior of a container from whichthe fluids are being transferred.

Another advantage is that rotation of the aseptic connector removes acap from a fill connector of a container and exposes a septum, theseptum providing a secondary barrier to the environment.

Yet another advantage is that after removing the evacuated container,the aseptic connector maintains the sterility of the tube and/orcontainer to which the fluids were transferred.

A further advantage is that the aseptic connector includes a stop toprevent repeated use of the aseptic connector after the evacuatedcontainer has been removed.

Other features and advantages of the present invention will be apparentfrom the following more detailed description of exemplary embodimentsthat illustrate, by way of example, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an aseptic connector, according to anembodiment of the disclosure.

FIG. 2 is a cross-sectional view of the aseptic connector of FIG. 1.

FIG. 3 is a perspective view of an aseptic connector attached between aflexible container and flexible tubing.

FIG. 4 is a schematic view of the operation of an aseptic connector.

FIG. 5 is a perspective view of a dial type aseptic connector, accordingto an embodiment of the disclosure.

FIG. 6 is a perspective view of a sliding type aseptic connector,according to an embodiment of the disclosure.

Wherever possible, the same reference numbers will be used throughoutthe drawings to represent the same parts.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1 and 2, an aseptic connector 100 includes a bodyportion 101, a pivot portion 103, and a conduit portion 105. The conduitportion 105 is axially slidably disposed within a channel 107 formed inthe pivot portion 103. In one embodiment, the pivot portion 103 isadjustably disposed within, and partially extends from, the body portion101. A thin layer of a soft, sealing material may be disposedintermediate a region of the outer surface of the pivot portion 103 andthe inner surface of the body portion 101 to act as a seal, preventingleaks and maintaining sterility. This and other seals are optionallyincluded within the connector as desired.

In one embodiment, the aseptic connector 100 is pivotable in a singledirection, transitioning from a ready position (as shown in FIG. 1), toan active position (i.e., fill/evacuate position) and from that positionto a closed position as will be described in more detail subsequently.In another embodiment, the body portion 101 may be configured withtravel stops to establish a range of motion for the pivot portion 103between the ready, active, and/or closed positions, defining singledirectional movement between positions and preventing over or underrotation. The travel stops may further provide a palpable signal to theuser that the aseptic connector 100 is in the proper position. In afurther embodiment, the aseptic connector 100 is a single use asepticconnector, including a feature for preventing re-use of the asepticconnector 100 for another connection after removal.

The aseptic connector 100 may be formed from any material suitable forsterilization. Suitable materials include, but are not limited to,plastic resins, preferably those selected from grades suitable formedical and/or life science use (e.g., materials class VI) and which arealso resistant to high temperatures and gamma radiation to permit steamand/or gamma sterilization procedures that render the aseptic connectorsterile prior to use. In one embodiment, sterilization of the asepticconnector 100 may be accomplished through autoclave sterilization at270° F. (132° C.) for 60 minutes. In another embodiment, the asepticconnector 100 is resistant to up to 25 or more repetitions of thesterilization. Other embodiments include sterilization through gammairradiation, e-beam sterilization, EtO sterilization, or a combinationthereof. For gamma irradiation and/or e-beam sterilization, the asepticconnector 100 is resistant to a maximum cumulative exposure of up to 50Kilograys. For EtO sterilization, the aseptic connector 100 is resistantto 100% EtO at 110° F. (43° C.) for up to five repetitions. It will beappreciated that sterilization should be done in an uncoupled position.

As illustrated in FIG. 2, the conduit portion 105, which is shown as amale connection, is connected to flexible tubing 205 to extend the fluidflow path to some other container or other location to which the fluidis to be delivered. The conduit portion 105 may include a raised wall207 to provide a travel stop, the travel stop establishing anappropriate overlap length of the tubing 205. The conduit portion 105may also include one or more raised ribs 208 and/or a flared outlet 209to aid in retaining the tubing 205 securely on the conduit portion 105during use. Additionally, the one or more raised ribs 208 and/or theflared outlet 209 reduce the possibility of leaking that would therebycompromise the aseptic nature of the fluid path.

The aseptic connector 100 also includes a receptacle 210 formed in thebody portion 101. The receptacle 210 is configured to receive a fillconnector 212 appended to a fluid source, such as a filled flexiblecontainer or other suitable container 301 (see FIG. 3) from which liquidis to be aseptically evacuated. For example, in one embodiment, theaseptic connector 100 includes a female receptacle configured to receivea male fill connector of the container 301, thus connecting the asepticconnector 100 to the container 301. In another embodiment, receptacle210 of the aseptic connector 100 directly connects with the fillconnector 212 through any suitable connection mechanism. Suitableconnection mechanisms include, but are not limited to, a threadedconnection, a trapezoid thread on the outer diameter of the fillconnector 212, a locking or snapping connection, or a combinationthereof. In a preferred embodiment, the fill connector 212 is of thetype described in U.S. Pat. No. 7,530,374 and/or those used in theflexible containers sold by Advanced Scientifics of Millersburg, Pa.which are adapted to interface with attachments.

In the ready configuration shown in FIG. 2, a recess 214 in the pivotportion 103 is aligned with receptacle 210. The recess 214 is configuredto receive a cap 216 of the fill connector 212 when the fill connector212 is attached to the receptacle 210, and the aseptic connector 100 inthe ready position. Together, the aseptic connector 100, the fillconnector 212 attached to the receptacle 210, and the container 301extending from the fill connector 212 form a fluid transfer assembly.Even with the aseptic connector 100 secured in its position along thefluid flow path, the body portion 101 is not in fluid communication withthe conduit portion 105 when the aseptic connector 100 is in the readyposition. As body portion 101 is not in fluid communication with theconduit portion 105, the flexible container 301 is not in fluidcommunication with the flexible tubing 205 for the flow of liquidcontent therethrough.

Referring to FIG. 3, the aseptic connector 100 is shown in its active,evacuate position, in which the pivot portion 103 is rotated into aposition that aligns the conduit portion 105 residing in the channel 107of the pivot portion 103 with the opening in the female receptacle 210.The aligning of the conduit portion 105 with the female receptacle 210also aligns the conduit portion 105 with the fill connector 212 attachedthereto. In addition, the rotation of the pivot portion 103 from theready to the active position breaks the fill connector cap 216 away fromthe fill connector 212. In one embodiment, for example, the rotation ofthe pivot portion 103 disengages the cap 216 with ten pounds of force orless. The breaking away of the cap 216 exposes a septum 218 in the fillconnector 212 as a secondary barrier to the environment. Because thisinterface of the aseptic connector 100 and fill connector 212 was notexposed to the environment, it remains a sterile portion of a closedpathway.

After the aseptic connector 100 has been placed in the active position,and the conduit portion 105 is aligned with the receptacle 210, theconduit portion 105 can be moved axially into the fill connector 212. Ataper 221 (see FIG. 2) or spike may be formed at the proximal end of theconduit portion 105 to more easily penetrate any septum 218 thatunderlies the cap 216 of the fill connector 212. In one embodiment, thewall 207 on the outer diameter of the conduit portion 105 isconveniently used to also establish the proper penetration depth of theconduit portion 105 through the body portion 101 into the fill connector212. For example, the wall 207 on the conduit portion 105 may establishthe proper penetration depth by contacting a complementary wall 109 (seeFIGS. 1 and 2) of an extension of the pivot portion 103. In addition toor in place of the wall 207, any other mechanism by which the depth ofthe conduit portion 105 into the fill connector 212 can be controlledmay be used. A mechanical stop may also be employed in the pivot portion103 and/or the conduit portion 105 to prevent the conduit portion's 105unintentional removal from the aseptic connector 100 (for example, whenretracting the conduit portion from the fill connector after use).

Once the conduit portion 105 has been moved axially into the fillconnector 212 and/or the septum 218 is penetrated, a continuous fluidflow path is established through the aseptic connector 100 between theflexible container 301 and the flexible tubing 205. The continuous fluidflow path permits aseptic evacuation of the contents of the flexiblecontainer 301 through the aseptic connector 100 and flexible tubing 205to another location. According to exemplary embodiments, the asepticconnector 100 provides for aseptic fill and evacuation at pressures ofup to 125 psi (8.6 bar), and temperatures of between −40° F. (−40° C.)and 280° F. (138° C.), although greater pressures and temperatures arepossible.

After the transfer is completed, the conduit portion 105 is retracted.The pivot portion 103 is rotated another step to the closed position,which is the final position of the aseptic connector 100. To assuresterility, once moved to the closed position, the pivot portion 103cannot be returned to the active position. That is, it is locked inplace and an operator cannot move the pivot portion 103 relative to thebody portion 101.

At this point, the aseptic connector 100 can be detached from the fillconnector 212 (typically by unscrewing when using the preferred threadedconnection). The aseptic connector 100, or at least that portion of itincluding the conduit portion 105, having been transitioned to itsclosed position prior to removing the fill connector 212, remainssterile. While the fill connector side (i.e. the female receptacle ofthe base portion) is considered jeopardized by exposure to theenvironment following removal from the body portion 101, the closedposition seals that exposure from the interior of the aseptic connector100, including the conduit portion 105. Furthermore, the contents of theflexible container 301 are presumably evacuated to the extent desired(preferably until empty in most instances) and the sterility of thedisconnected fill connector 212 itself at that point is also of littleconcern.

Referring to FIG. 4, a method of operating the aseptic connector 100includes, aligning the fill connector 212 of the flexible (or otherstyle of) container housing liquid contents to be aseptically evacuatedwith the receptacle 210 of the aseptic connector body portion 101 (step401). The aligning of the fill connector 212 with the receptacle 210 isperformed with the aseptic connector 100 staged in the ready position.The fill connector 212 is then fully secured to the receptacle 210 ofthe aseptic connector 100 (step 403). As illustrated in FIG. 4, theconnector 212 is screwed onto the receptacle 210, although any othersecuring mechanism may be used. After securing the fill connector 212 tothe receptacle 210, the fill connector cap 216 is seated within therecess in the pivot portion 103 of the aseptic connector 100.

Next, the pivot portion 103 is rotated into the active position (step405), breaking off the fill connector cap 216. As illustrated, the bodyportion 101 includes a side opening that allows the cap 216 to beejected (step 407) from the aseptic connector 100 after being broken offof the fill connector 212. After rotating the pivot portion 103 into theactive position, the conduit portion 105 is axially slid into the fillconnector 212 in the receptacle 210 (step 409), piercing any septum inthe fill connector 212, and establishing fluid communication through theaseptic connector 100 to evacuate the contents of the flexible container301.

After evacuation is complete, the conduit portion 105 is retracted fromthe fill connector 212 (step 411) and the pivot portion 103 is rotatedanother increment to a closed position (step 413), closing the flow pathon the conduit portion side, and permitting the subsequent removal ofthe now-evacuated flexible container 301 for disposal, while retainingthe aseptic flowpath from the aseptic connector 100 to the flowpath'sterminus.

As a result, the aseptic connector 100 of the invention, when used inconjunction with a sterile fill system such as the one described,provides a system that allows fill and evacuation aseptically throughthe same port of a flexible container 301. In a preferred embodiment,the aseptic connector meets compliance specifications for one or more ofthe following: ISO 10993, NAO, Cytotoxity, and is BPA, DEHP, Latexand/or Melamine free. Furthermore, in a preferred embodiment, theaseptic connector is capable of meeting some or all of the followingtests, the procedures for which are known to those of ordinary skill inthe art: Bacterial Challenge, Microbial Ingress Test, Steam Leak Test,Helium Leak Test, Burst Test, Flow Test, Tensile Test, Creep-RuptureTest, Biocompatibility Tests, Functional Testing after AcceleratedAging, Bubble Leak Test, Endotoxin Test, Bioburden Test, and TotalOrganic Compounds (TOC).

Alternative embodiments are shown in FIGS. 5 and 6, which illustrateother mechanical arrangements that demonstrate an aseptic connector 100having one-directional advancement from ready to active to closedpositions. FIG. 5 illustrates a dial type connector 501, while FIG. 6illustrates a sliding type connector 601. While the manner in whichrelative movement of the body portion 101 with respect to the pivotportion 103 is different, the effect is the same as describedpreviously, with the receptacle 210 receiving the fill connector 212,moving the pivot portion 103 with respect to the body portion 101 toalign the conduit portion 105 and/or spike and pierce the septum 218(see FIGS. 3-4) to permit fluid flow, followed by again moving the pivotportion 103 with respect to the body portion 101 to close the fluid flowpath to permit separation of the container 301 without loss of sterilityto the opposite end of the flow path. It will be appreciated that othermechanical arrangements are also contemplated that fall within theconcept of the invention of providing an aseptic connector that mateswith a fill connector of a container and thus permits sterile fillingand evacuation of the container by the same port.

It will be appreciated that the references to fill connector and asepticconnector as used herein is primarily for purposes of differentiatingmechanical parts and while named with respect to the convention of apreferred embodiment, is not intended as a limitation on use or todefine the direction in which fluid necessarily flows.

While the invention has been described with reference to a preferredembodiment, it will be understood by those skilled in the art thatvarious changes may be made and equivalents may be substituted forelements thereof without departing from the scope of the invention. Inaddition, many modifications may be made to adapt a particular situationor material to the teachings of the invention without departing from theessential scope thereof. Therefore, it is intended that the inventionnot be limited to the particular embodiment disclosed as the best modecontemplated for carrying out this invention, but that the inventionwill include all embodiments falling within the scope of the appendedclaims.

What is claimed is:
 1. A method for forming an aseptic connection, themethod comprising: inserting an end of a sealed fill connector into areceptacle of an aseptic connector assembly; moving a pivot portion ofthe aseptic connector assembly relative to a body portion of the asepticconnector assembly so that the pivot portion severs a portion of thefill connector, the pivot portion being at least partially disposedwithin the body portion; and advancing a conduit portion of the asepticconnector assembly into the fill connector so as to form an asepticconnection therebetween, the conduit portion being at least partiallydisposed within the pivot portion or the body portion of the asepticconnector assembly prior to advancing.
 2. The method according to claim1, wherein the step of inserting comprises inserting the portion of thefill connector into a recess formed on the pivot portion.
 3. The methodaccording to claim 2, wherein the portion of the fill connector comprisea frangible cap.
 4. The method according to claim 2, wherein the step ofmoving comprises rotating or sliding the pivot portion relative to thebody portion from a ready position to an active position.
 5. The methodaccording to claim 4, wherein the recess is aligned with the receptaclewhen the pivot portion is in the ready position and the recess is notaligned with the receptacle when the pivot portion is in the activeposition.
 6. The method according to claim 1, wherein severing theportion of the fill connector exposes a septum in the fill connector. 7.The method according to claim 6, wherein the step of advancing theconduit portion causes the conduit portion to penetrate the septum. 8.The method according to claim 6, further comprising a septum penetratingmember formed on the conduit portion, the septum penetrating memberbeing selected from the group consisting of a taper, a spike, andcombinations thereof.
 9. The method according to claim 1, wherein thestep of advancing the conduit portion comprises sliding the conduitalong a longitudinal axis of the conduit portion.
 10. The methodaccording to claim 1, further comprising passing a liquid between thefill connector and the conduit portion.
 11. The method according toclaim 1, further comprising: withdrawing the conduit portion of theaseptic connector assembly from the fill connector; and further movingthe pivot portion of the aseptic connector assembly relative to the bodyportion so as to seal off access to the conduit portion.
 12. The methodaccording to claim 11, further comprising removing the fill connectorfrom the receptacle of the aseptic connector assembly following the stepof further moving the pivot portion.
 13. A method for forming an asepticconnection, the method comprising: inserting an end of a sealed fillconnector into a receptacle of an aseptic connector assembly so that aportion of the fill connector is received within a recess on a pivotportion of the aseptic connector assembly; rotating or sliding the pivotportion of the aseptic connector assembly relative to a body portion ofthe aseptic connector assembly so that the pivot portion severs theportion of the fill connector within the recess and exposes a septum inthe fill connector; and advancing a conduit portion of the asepticconnector assembly so as to penetrate the septum and form an asepticconnection with the fill connector.
 14. The method according to claim13, wherein the portion of the fill connector received within the recesscomprises a frangible cap.
 15. The method according to claim 13, furthercomprising passing a liquid between the fill connector and the conduitportion.
 16. The method according to claim 13, further comprising:withdrawing the conduit portion of the aseptic connector assembly fromthe fill connector; and further rotating the pivot portion of theaseptic connector assembly relative to a body portion so as to seal offaccess to the conduit portion.
 17. The method according to claim 16,further comprising removing the fill connector from the receptacle ofthe aseptic connector assembly following the step of further rotatingthe pivot portion.
 18. A method for forming an aseptic connection, themethod comprising: rotating or sliding a pivot portion of an asepticconnector assembly relative to a body portion of the aseptic connectorassembly so that the pivot portion severs a frangible cap of the fillconnector; advancing a conduit portion of the aseptic connector assemblyso as to penetrate a septum on a fill connector and form an asepticconnection between the conduit portion and the fill connector, the fillconnector being removably coupled to the aseptic connector assembly;passing a liquid between the fill connector and the conduit portion;withdrawing the conduit portion of the aseptic connector assembly fromthe fill connector; moving a pivot portion of the aseptic connectorassembly relative to a body portion of the aseptic connector assembly soas to seal off access to the conduit portion; and removing the fillconnector from the aseptic connector.